Depression
Conditions
Keywords
Depressive Disorder, Major, Cognitive Behavioral Therapy, Psychotherapy, Telemedicine, Primary Care
Brief summary
This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression.
Detailed description
Major depressive disorder is a common and often long-lasting disorder with 12-month prevalence rates estimated to be between 6.6% and 10.3%. Although the personal and societal costs of depression are high, it is well established that depression can be effectively treated using antidepressant medication and/or forms of psychotherapy. Several studies have found that when given a choice, about two-thirds of depressed patients prefer psychotherapy or counseling over antidepressant medication. However, a variety of barriers exist to initiating and maintaining psychotherapy. Only about 20% of all patients referred for psychotherapy actually initiate treatment, and of those who do initiate treatment, nearly half drop out before completing treatment. The use of the telephone to deliver treatment services has been recommended as a way to reduce many of the barriers associated with failure to initiate and sustain treatment. When administered over the telephone, cognitive behavioral therapy (CBT), a form of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to depression, may be superior to face-to-face CBT in improving treatment adherence and reducing depressive symptoms. This study will compare the effectiveness of telephone CBT (T-CBT) versus face-to-face CBT (FtF-CBT) in treating people with depression. Participation in this study will include 18 weeks of treatment and 12 months of follow-up. All participants will first undergo baseline assessments that will include a telephone interview and questionnaires about mood. Participants will then be assigned randomly to receive T-CBT or FtF-CBT. Participants in both groups will receive eighteen 45-minute sessions of their assigned treatment over 18 weeks. Sessions will occur twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. During sessions, participants will learn ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made. Treatment sessions will be identical for both groups, except one group will receive sessions over the telephone and the other in-person at a study office. All participants will repeat the baseline assessments at Weeks 4, 9, 14, and 18 of treatment and Months 3, 6, 9, and 12 of follow-up.
Interventions
BEHAVIORALTelephone-administered cognitive behavioral therapy (T-CBT)
Over 18 weeks, participants will receive eighteen 45-minute sessions of T-CBT administered by a therapist. Participants will undergo telephone-administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
BEHAVIORALFace-to-face administered CBT (FtF-CBT)
Over 18 weeks, participants will receive eighteen 45-minute sessions of FtF-CBT administered by a therapist. Participants will undergo face-to-face administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
Sponsors
National Institute of Mental Health (NIMH)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has a current diagnosis of major depressive disorder * Has a primary care physician at Northwestern University in Illinois, or one of a number of approved community clinics in Chicago. * Resides in Illinois * Has a telephone * Speaks and reads English
Exclusion criteria
* Hearing, voice, or visual impairment * Meets criteria for dementia * Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous * Currently receiving individual psychotherapy or planning to receive psychotherapy during the treatment phase of the study * Planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time * Recent history of suicide attempts or is severely suicidal * Initiated treatment with an antidepressant in the 2 months before study entry (antidepressant medication is not exclusionary) * Depression determined to be primarily of an organic etiology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attrition (Number of Therapy Sessions Attended) | Post treatment, up to 18 weeks | Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected. |
| Number of Participants Who Dropped Out of Therapy | Post treatment, up to 18 weeks | Using the number of therapy sessions attended, we categorized patients into: 1. those who discontinued treatment before session 18, and those who completed session 18. 2. those who discontinued before Session 5, and those who continued. |
| Patient Health Questionnaire (PHQ)-9 | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up | Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment. |
| Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up | Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant. |
Secondary
| Measure | Time frame |
|---|---|
| Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form) | Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from November 2007 to December 2010 from general internal medicine clinics in Northwestern Medical Faculty Foundation and Northwestern Memorial Physician's Group, and from 4 primary care clinic members of Northwestern's Practice-Based Research Network.
Participants by arm
| Arm | Count |
|---|---|
| Telephone-administered CBT Participants will receive telephone-administered cognitive behavioral therapy. | 163 |
| Face-to-face CBT Participants will receive face-to-face cognitive behavioral therapy. | 162 |
| Total | 325 |
Baseline characteristics
| Characteristic | Face-to-face CBT | Telephone-administered CBT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 13 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 148 Participants | 150 Participants | 298 Participants |
| Age Continuous | 47.5 years STANDARD_DEVIATION 13.5 | 47.8 years STANDARD_DEVIATION 12.6 | 47.6 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment United States | 162 participants | 163 participants | 325 participants |
| Sex: Female, Male Female | 127 Participants | 125 Participants | 252 Participants |
| Sex: Female, Male Male | 35 Participants | 38 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 163 | 0 / 162 |
| serious Total, serious adverse events | 0 / 163 | 0 / 162 |
Outcome results
Primary
Attrition (Number of Therapy Sessions Attended)
Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.
Time frame: Post treatment, up to 18 weeks
Population: A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telephone-administered CBT | Attrition (Number of Therapy Sessions Attended) | 15.4 Number of Sessions | Standard Deviation 4.4 |
| Face-to-face CBT | Attrition (Number of Therapy Sessions Attended) | 13.7 Number of Sessions | Standard Deviation 6.1 |
p-value: 0.003t-test, 2 sided
Primary
Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)
Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.
Time frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone-administered CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week09 | 15.62 units on a scale | — |
| Telephone-administered CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week18 | 13.58 units on a scale | — |
| Telephone-administered CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week04 | 18.07 units on a scale | — |
| Telephone-administered CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | 3-month follow-up | 14.58 units on a scale | — |
| Telephone-administered CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week14 | 14.94 units on a scale | — |
| Telephone-administered CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | 6-month follow-up | 15.06 units on a scale | — |
| Telephone-administered CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Baseline | 22.83 units on a scale | Full Range 4.6 |
| Face-to-face CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | 6-month follow-up | 12.14 units on a scale | — |
| Face-to-face CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Baseline | 22.83 units on a scale | Full Range 4.6 |
| Face-to-face CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week04 | 17.86 units on a scale | — |
| Face-to-face CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week09 | 16.45 units on a scale | — |
| Face-to-face CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week14 | 14.18 units on a scale | — |
| Face-to-face CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | Week18 | 12.51 units on a scale | — |
| Face-to-face CBT | Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D) | 3-month follow-up | 12.33 units on a scale | — |
Comparison: Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.p-value: 0.2295% CI: [-0.63, 2.76]Mixed Models Analysis
Primary
Number of Participants Who Dropped Out of Therapy
Using the number of therapy sessions attended, we categorized patients into: 1. those who discontinued treatment before session 18, and those who completed session 18. 2. those who discontinued before Session 5, and those who continued.
Time frame: Post treatment, up to 18 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telephone-administered CBT | Number of Participants Who Dropped Out of Therapy | those who discontinued treatment before session 18 | 34 participants |
| Telephone-administered CBT | Number of Participants Who Dropped Out of Therapy | those who discontinued before Session 5, | 7 participants |
| Face-to-face CBT | Number of Participants Who Dropped Out of Therapy | those who discontinued treatment before session 18 | 53 participants |
| Face-to-face CBT | Number of Participants Who Dropped Out of Therapy | those who discontinued before Session 5, | 21 participants |
p-value: 0.02Chi-squared
p-value: 0.006Chi-squared
Primary
Patient Health Questionnaire (PHQ)-9
Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.
Time frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone-administered CBT | Patient Health Questionnaire (PHQ)-9 | Baseline | 16.76 units on a scale | Full Range 4.7 |
| Telephone-administered CBT | Patient Health Questionnaire (PHQ)-9 | Week04 | 10.78 units on a scale | — |
| Telephone-administered CBT | Patient Health Questionnaire (PHQ)-9 | Week09 | 9.05 units on a scale | — |
| Telephone-administered CBT | Patient Health Questionnaire (PHQ)-9 | Week14 | 8.55 units on a scale | — |
| Telephone-administered CBT | Patient Health Questionnaire (PHQ)-9 | Week18 | 6.65 units on a scale | — |
| Telephone-administered CBT | Patient Health Questionnaire (PHQ)-9 | 3-month follow-up | 7.59 units on a scale | — |
| Telephone-administered CBT | Patient Health Questionnaire (PHQ)-9 | 6-month follow-up | 8.42 units on a scale | — |
| Face-to-face CBT | Patient Health Questionnaire (PHQ)-9 | Week14 | 7.77 units on a scale | — |
| Face-to-face CBT | Patient Health Questionnaire (PHQ)-9 | Baseline | 16.76 units on a scale | Full Range 4.8 |
| Face-to-face CBT | Patient Health Questionnaire (PHQ)-9 | 3-month follow-up | 6.60 units on a scale | — |
| Face-to-face CBT | Patient Health Questionnaire (PHQ)-9 | Week04 | 10.09 units on a scale | — |
| Face-to-face CBT | Patient Health Questionnaire (PHQ)-9 | Week18 | 6.74 units on a scale | — |
| Face-to-face CBT | Patient Health Questionnaire (PHQ)-9 | Week09 | 8.62 units on a scale | — |
| Face-to-face CBT | Patient Health Questionnaire (PHQ)-9 | 6-month follow-up | 6.30 units on a scale | — |
Comparison: Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.p-value: 0.8995% CI: [-1.35, 1.17]Mixed Models Analysis
Secondary
Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)
Time frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up